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FDA warns Novartis about facebook widget

Drug company Novartis recently received a warning letter from the Food and Drug Administration’s Division of Drug Marketing, Advertising, and Communications about a widget enabling visitors to the Web site for the company’s drug Tasigna to share information with their Facebook friends.

The FDA claimed that the widget for Tasigna, a leukemia drug, violated federal regulations because it made representations about the drug’s efficacy and failed to communicate any risk information. Tasigna’s Web site offered Novartis-created information about the drug that Facebook users could “share” with their friends by posting it on their wall or sending it as a separate message. For example, one item read, “In addition to taking Tasigna (nilotinib) 200-mg capsules, talking to your doctor and receiving health tips can help you treat your CML [chronic myeloid leukemia].”

“By failing to disclose any risk information for Tasigna, the shared content misleadingly suggests that Tasigna is safer than has been demonstrated by substantial evidence or substantial clinical experience,” the letter stated. The FDA noted that the shared content included a hyperlink to Tasigna Web sites, which do contain risk information, but said that wasn’t enough. “The inclusion of such a hyperlink is insufficient to mitigate the misleading omission of risk information from these promotional materials. For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug,” the FDA said.

The letter requested that Novartis immediately cease the dissemination of the promotional materials, which the company did. In a statement, the company said it “will continue to have active discussions with the FDA to understand fully all of the concerns. We also will assess all of our Web assets and materials based on these concerns.”

Why it matters: Because drug advertising faces stricter regulation than other industries, companies have expressed concern about meeting their requirements in the world of social media. In April, pharmaceutical companies filed written statements with the FDA, urging it to adopt guidelines specific to Web marketing and the use of social media, arguing that it is impossible to convey the risk information required in other forms of advertising in a 140-character Tweet or an Internet banner ad. While the FDA has set no timetable for issuing such guidelines, its letter to Novartis – the first sent directly addressing marketing efforts on Facebook – highlights the fact that the agency is monitoring the use of social media.

Compare jurisdictions:Life Sciences: Product Regulation and Liability

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